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临床试验/NCT05365763
NCT05365763已完成不适用

Developing an Experimental Framework to Evaluate Oncologist Emotion Regulation and Its Effect on Prognostic Disclosure During Telehealth Encounters

Dartmouth-Hitchcock Medical Center1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2020年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
11
试验地点
1
主要终点
Investigator Assessed Feasibility of collecting clinician derived data on emotion regulation

研究概览

简要总结

The research team recruited physicians (medical oncologists and specialty palliative care providers) trained in a communication tool called the serious illness conversation guide. Physicians conducted a simulated, telehealth serious illness conversation with an actor playing the role of a patient with advanced cancer. Physicians completed psychologic inventories before and after the encounter, documented the encounter using a template in the electronic medical record, and then participated in a structured interview afterwards discussing what they were feeling during the encounter and how it impacted the encounter. Physicians also wore three heart rate variability sensors during the simulated encounter.

详细描述

Aim 1: Assess the feasibility and acceptability of measuring physician emotion regulation (ER) abilities and strategies when disclosing prognosis in a simulated, outpatient telehealth encounter with a patient with advanced cancer.

This works seeks to address a technical gap in measurement relevant to the field of serious illness communication by assessing the feasibility and acceptability of collecting psychologic inventories and physiologic data in clinicians during a simulated patient encounter. The research team will purposely recruit physician of varied communication skill, assess communication behavior and triangulate different measures of emotion and ER (e.g. self-report, observation and biometric data sources). This exploratory aim will provide information regarding the feasibility of collecting data from physicians, variability in predictor (ER abilities) and outcome (prognostic disclosure and responding to patient emotion) measures, and preliminarily assess the construct validity of novel measures of physician ER. The research team plan to use an iterative approach (aka adaptive design); results and analysis from the first participants will be used to influence data collection moving forward for future participants (e.g. interview questions asked, timing and duration of biometric sensors being worn, etc.). See Section 4.0 for the definition of feasibility.

Note: The rationale for using telehealth is for human subjects' protections in the context of COVID-19 era infection control practices. Specifically, subject health care providers and study actors cannot currently meet inside in person without wearing masks. Masks will adversely affect the study of communication and emotion. Given that serious illness conversations are increasingly occurring by telehealth in the COVID-19 era, this scientific change could be considered a strength as the research team seeks to learn more about the exchangeability of telehealth for in-person clinical services.

Aim 2: Compare and test two wearable biometric sensors against wearable ECG chest band (gold standard) to evaluate reliability, accuracy, and ease of use from participant and investigator perspectives. The study purpose is to critically appraise the less expensive sensor versus the more expensive research model in different tasks (resting vs patient encounter vs interview) and over different domains (reliability, accuracy, ease of use). To compare the sensors, each participant will wear all three: (one on each arm and the chest band) during the encounter. The research team will define the benchmark for reliability as heart rate variability available ≥90% of the task against the gold standard (e.g. ECG chest band). The research team will use feedback from investigators and participants to grade ease of use. Accuracy will be measured in terms of the time-weighted absolute difference in resting heart rate variability between the consumer and the gold standard sensor.

Aim 3: Assess the correlation between study clinicians' documentation of serious illness conversations using an electronic template against independent expert review and documentation of the video-recorded and transcribed conversation.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinicians who have been previously trained in the serious illness conversation guide. Two groups of participants will be recruited.
  • hematology/oncology faculty
  • specialty-trained palliative care clinicians

排除标准

  • individuals who have a diagnosis of cardiovascular dysfunction

结局指标

主要结局

Investigator Assessed Feasibility of collecting clinician derived data on emotion regulation

时间窗: Day 1

This is a composite measure with four criteria: 1) \>60% approached clinicians enroll on study; 2) \<5% of missing time from encounter audio file; 3) \<20% of missing time from heart rate variability collection; and 4) survey completion rates \>90% of all items. All four criteria must be met for investigators to assess as feasible.

次要结局

  • The number of participants with heart rate variability data collected for more than 90% of the conversation task(Day 1)
  • Completeness of Documentation(Day 1)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Garrett T. Wasp

Assistant Professor

Dartmouth-Hitchcock Medical Center

研究点 (1)

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